MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC BALL HEAD 28M; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number 75004170

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 03/31/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to dislocation.The doctor did not fault the devices as defective.The two implants were removed and other s&n devices were implanted.No delay or other complications were reported during the revision.

Manufacturer Narrative

It was reported that during procedure , while the surgeon was impacting the femoral head component, the polarstem modular head (75023711) cracked and broke off.According to the complainant, no pieces were left in the patient they.The device used during treatment was returned for investigation.The reported failure mode could be confirmed upon visual inspection.The modular head (750023711) is designed to impact a ball head on the polarstem taper.It is therefore subjected to repeated impact forces.Additionally, repeated steam sterilization processes could contribute to an embrittlement.It is however unknown for how many cycles this instrument has been used.A functional test simulating 5 years of use was performed.The reported failure mode could however not be reproduced.The root cause stays undetermined after investigation.Nonetheless, in combination with our continuous effort to improve our products, further investigations started to evaluate the root cause of this failure.The returned device will be discared.

Manufacturer Narrative

It was reported that a revision surgery was performed due to dislocation.The ceramic ball head (75004170) intended for use in treatment was not returned for investigation.An evaluation of the device could therefore not be conducted and the reported failure mode not independently be confirmed.A medical investigation was performed.Based on the limited information provided, a thorough medical assessment could not be performed.The patient activity and/or trauma status remains unknown.A review of the complaint history revealed no additional complaint for the batch in question (b0804173).A review of the batch record revealed no deviation from the standard manufacturing process that could have contributed to the reported dislocation.The device was manufactured in 2008.Review of the risk management documentation verifies the failure mode and severity of the reported issue.The ifu (lit.No.12.23 ed.09/05) identifies dislocation as a known possible side effect resulting from a hip arthroplasty.There is no indication that the device failed to match specifications at the time of manufacturing.Based on the conducted investigation the root cause for the reported dislocation cannot clearly be identified and stays undetermined.The need for corrective action is not indicated.Nevertheless, smith and nephew will continue to monitor the device for similar issues.The complaint will be reopened should additional information or the complaint device be received.

• Brand Name: CERAMIC CERAMIC BALL HEAD 28M
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; aarau 06340 ; SZ 06340
• MDR Report Key: 10075940
• MDR Text Key: 191592270
• Report Number: 9613369-2020-00087
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K070928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 75004170
• Device Lot Number: B0804173
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention